Medication Information & Informed Consent

This information explains why my Physician (AKA, my physician at Arizona Endocrinology) may recommend medication, how it is used, the possible benefits, the possible side effects and serious risks, and other choices I may have. My Physician will discuss my individual risks with me and answer my questions before treatment. I may choose not to take medication. Choosing no treatment is always an option.

Testosterone Cypionate — Injection

When my Physician recommends testosterone, it is because my symptoms, examination, and/or laboratory results suggest that testosterone treatment may be appropriate for me. Testosterone may help improve symptoms of low testosterone, such as low sex drive, low energy, loss of muscle, or reduced sense of well-being. Testosterone treatment is not right for everyone, and my Physician will review my health history and laboratory results before starting treatment and at regular intervals to monitor efficacy and safety. I also understand that sharing my medication is not only illegal but could be potentially dangerous to another person, and I agree that I will never share my medication with anyone.

Testosterone cypionate is usually given by injection. My dose and schedule will be based on my symptoms, testosterone levels, and treatment goals. My dose may change over time based on how I respond and what my laboratory tests show.

Common side effects can include acne or oily skin, changes in mood or sex drive, fluid retention or swelling, breast tenderness, and pain, redness, or irritation where I receive the injection. Testosterone can decrease sperm production and fertility and can cause the testicles to become smaller. These effects may be important if I am trying to have children.

Testosterone can increase my red blood cell count. If the count becomes too high, my blood may become thicker, and my risk of a blood clot may increase. For this reason, I will get my blood count checked during treatment. Testosterone can also affect cholesterol levels, cause fluid retention, and worsen sleep apnea in some people. I will follow up with my primary care physician regularly to monitor other aspects of my health. Testosterone may affect the prostate, including worsening urinary symptoms in men with an enlarged prostate. My Physician will monitor my PSA and prostate health when appropriate and may withhold medication until we confirm treatment is safe.

There are also serious risks that I need to understand. Blood clots, including blood clots in the legs or lungs, have been reported with testosterone treatment. Testosterone labeling also includes a warning about possible cardiovascular risk. The exact risk for me can vary, so my Physician will consider my personal health history before and during treatment, and I will regularly see my primary care provider to also monitor my health.

I will seek urgent medical care for chest pain, trouble breathing, sudden weakness or numbness, severe headache, one-sided leg swelling or pain, or other symptoms that could mean a blood clot, stroke, or other serious problem.

Other choices include a testosterone cypionate/propionate blend, testosterone pellets, or no testosterone treatment. My Physician will discuss which option is most appropriate for me.

My Physician will monitor my symptoms and appropriate laboratory tests during treatment. My dose may be changed, or treatment may be stopped if the risks become greater than the expected benefits.

By signing this consent, I understand why testosterone has been recommended. I understand the possible benefits, common side effects, serious risks, alternatives, and the option of no treatment. I have had an opportunity to ask questions, and my questions have been answered.

Testosterone Cypionate/Propionate Blend — Injection

When my Physician recommends this medication, it is because testosterone treatment is appropriate for me and this combination of two forms of testosterone may provide a different pattern of testosterone levels than testosterone cypionate alone.

The medication is given by injection according to the treatment schedule my Physician chooses for me. My dose may be changed based on my symptoms and laboratory results.

The possible side effects are similar to those of testosterone cypionate. I may have acne, oily skin, mood changes, changes in sex drive, fluid retention, breast tenderness, smaller testicles, reduced sperm production and fertility, or pain, redness, or irritation at the injection site. I may have more soreness or irritation from the injection.

Testosterone can increase my red blood cell count. If it becomes too high, this can increase my risk of blood clots. Testosterone can also affect cholesterol levels, cause fluid retention, worsen sleep apnea in some people, and affect the prostate. My Physician may monitor my blood count, testosterone levels, PSA, and other laboratory tests as appropriate.

Serious problems can include a blood clot, pulmonary embolism, cardiovascular problems, or significant fluid retention. I will seek urgent medical care for chest pain, trouble breathing, sudden weakness or numbness, severe headache, or other signs of a possible blood clot, stroke, or serious cardiovascular problem.

Other choices include standard testosterone cypionate, testosterone pellets, or no testosterone treatment.

By signing this consent, I understand the possible benefits, common side effects, serious risks, alternatives, and the option of no treatment. I have had the opportunity to ask questions, and my questions have been answered.

Testosterone Pellets

When my Physician recommends testosterone pellets, it is because testosterone treatment is appropriate for me and pellets are one way to provide testosterone over a longer period of time. The pellets are small implants placed under the skin and slowly release testosterone over time.

The pellets are placed during a minor office procedure. The dose is chosen before the procedure based on my treatment plan. One important difference between pellets and injections is that the dose cannot simply be changed or removed once the pellets have been placed. If my testosterone level becomes too high or I develop a side effect, the medication cannot be quickly removed in the same way an injection or oral medication can be stopped.

The possible medication side effects are similar to other forms of testosterone. These can include acne, mood changes, fluid retention, breast tenderness, smaller testicles, reduced sperm production and fertility, increased red blood cell count, changes in sex drive, worsening sleep apnea, and changes in prostate or urinary symptoms.

The pellet procedure also has its own risks. These include pain, bruising, bleeding, infection, scarring, poor healing, the pellet coming out through the incision, or the pellet moving from where it was placed. The separate pellet procedure consent explains these risks in more detail.

The general risks of testosterone treatment also apply to pellets. Testosterone can increase red blood cell count and may increase the risk of blood clots. It may affect cardiovascular health, cholesterol, sleep apnea, and the prostate. My Physician will monitor my symptoms and appropriate laboratory tests.

I will seek urgent medical care for chest pain, trouble breathing, sudden weakness or numbness, severe headache, or other symptoms that could indicate a blood clot, stroke, or other serious problem.

Other choices include injectable testosterone or no testosterone treatment.

By signing this consent, I understand that testosterone pellets provide treatment for a longer period of time and that the dose cannot be quickly changed after the pellets are placed. I understand the medication and procedure risks, alternatives, and option of no treatment.

Anastrozole

When my Physician recommends anastrozole, it is because it may be appropriate to lower the amount of estrogen my body makes. In some men receiving testosterone, estrogen levels may become higher than desired or may be associated with symptoms. If my Physician believes my estrogen level or symptoms need treatment, anastrozole may be used as part of my treatment plan.

My Physician will give me specific instructions about how much to take and how often to take it. My medication may be changed or stopped based on my symptoms and laboratory results.

Common side effects can include joint or muscle pain, headache, hot flashes, mood changes, and changes in sex drive. Anastrozole can also lower estrogen too much. Very low estrogen may affect sexual function, mood, cholesterol levels, and bone health.

Long-term low estrogen can decrease bone strength and increase my risk of osteoporosis and fractures. Anastrozole can also increase cholesterol levels. For these reasons, my Physician will consider my symptoms, laboratory results, and other risk factors when deciding whether this medication is appropriate for me.

Serious problems are uncommon, but long-term or excessive lowering of estrogen can cause significant problems with bone health and may affect cardiovascular risk factors.

Depending on my situation, another choice may be to change my testosterone dose or use a different treatment. In some patients, my Physician may decide that no medication is needed for an elevated estrogen level and instead monitor symptoms and laboratory results.

By signing this consent, I understand why anastrozole has been recommended, including its possible benefits, side effects, risks, alternatives, and the option of no treatment.

Enclomiphene

When my Physician recommends enclomiphene, it is because it may help my body make more of its own testosterone. Unlike testosterone injections or pellets, enclomiphene does not directly give me testosterone. It may be an option for some men who want to stimulate their own testosterone production and may be particularly useful when maintaining fertility is an important goal.

Enclomiphene is taken by mouth according to the treatment plan my Physician discusses with me. My response can vary, and it may not work well for me.

Possible side effects include headache, mood changes, changes in sex drive, breast tenderness, and changes in testosterone or estrogen levels.

One important warning involves vision. Medicines in this drug class can cause visual problems. If I develop new vision changes, I will stop the medication and contact my Physician promptly. If I have sudden or severe vision loss, I will seek urgent medical care. Eye-related and blood-clotting concerns have been reported with the related drug clomiphene, and FDA materials have discussed these safety concerns in connection with enclomiphene development.

Enclomiphene is not an FDA-approved drug for male testosterone replacement. If my prescription is compounded, the compounded product itself is not FDA-approved. FDA does not review compounded drugs before they are marketed to determine their safety, effectiveness, or quality in the same way it reviews FDA-approved drugs.

Other choices include testosterone treatment, HCG, or no treatment.

By signing this consent, I understand that enclomiphene is intended to stimulate my body's own testosterone production. I understand that it may not work for me and that there are possible side effects and risks. I understand my alternatives, including testosterone treatment and no treatment.

Nandrolone

When my Physician recommends nandrolone, a separate informed consent is required. 

Tadalafil

When my Physician recommends tadalafil, it is because it may help with my erectile dysfunction. It works by increasing blood flow to my penis when I am sexually stimulated. It does not automatically cause an erection.

Tadalafil can cause headache, flushing, a stuffy nose, indigestion, back pain, muscle aches, or dizziness. These side effects are usually mild, but they can be bothersome.

There is one very important medication interaction that I must understand. I will not take tadalafil with nitrate medicines, such as nitroglycerin. Taking tadalafil with nitrates can cause a dangerous drop in blood pressure. I will tell my Physician about all medicines I take, especially medicines for chest pain, blood pressure, or other erectile dysfunction medicines.

A rare but serious side effect is an erection that lasts more than four hours. This is called priapism. It can cause permanent damage if it is not treated quickly. If I have an erection that lasts more than four hours, I will go to an emergency department immediately. Rarely, sudden vision loss or sudden hearing loss has also been reported. If I develop sudden vision or hearing changes, I will seek urgent medical care.

Other choices include sildenafil or another erectile dysfunction medication, non-drug treatment, or no treatment.

By signing this consent, I understand how tadalafil works, its common side effects, serious risks, important drug interactions, alternatives, and the option of no treatment.

Progesterone — Low-Dose Oral Use With Testosterone

When my Physician recommends low-dose oral progesterone, it is because it may be appropriate as part of my testosterone treatment plan. In some men, progesterone may be used with testosterone when the goal is to support sleep or improve sleep quality. This is a treatment choice based on my individual situation, and it is not necessary for every man receiving testosterone.

I will take progesterone by mouth according to the dose and schedule my Physician gives me. It may make me sleepy or dizzy, so I will know how it affects me before driving or doing anything that requires me to be alert.

Possible side effects include sleepiness, dizziness, mood changes, breast tenderness, headache, changes in sex drive, or other hormone-related symptoms. Oral progesterone can cause drowsiness, so it is often taken at bedtime when appropriate.

Serious problems are uncommon, but I will contact my Physician if I develop severe mood changes, unusual symptoms, significant swelling, or other concerning reactions. I will seek urgent medical care for chest pain, trouble breathing, fainting, or symptoms of a serious allergic reaction.

Other choices include non-hormonal sleep support, other approaches to improving sleep, or no progesterone treatment.

By signing this consent, I understand why low-dose oral progesterone has been recommended with my testosterone treatment. I understand its possible benefits, side effects, risks, alternatives, and the option of no treatment.

HCG

When my Physician recommends HCG, it is because it may act like a natural hormone called LH. In some men receiving testosterone, HCG may help maintain testicular activity and testicular size and may help support sperm production. It does not guarantee that my fertility will be maintained.

HCG is given by injection according to my treatment plan. Possible side effects include injection-site pain or irritation, headache, mood changes, breast tenderness, bloating, or fluid retention.

HCG can change my hormone levels and may increase estrogen in some people. If my hormone levels change too much, I may notice breast tenderness, mood changes, swelling, or other symptoms. My Physician can adjust or stop treatment if needed.

I will seek medical care for severe swelling, severe headache, chest pain, trouble breathing, or another serious reaction.

Other choices include no HCG, enclomiphene, or a different treatment plan.

By signing this consent, I understand why HCG has been recommended. I understand that it may help support testicular function but does not guarantee fertility. I understand the possible side effects, risks, alternatives, and option of no treatment.

Levothyroxine / Liothyronine

When my Physician recommends thyroid hormone, it is because my body may not be making enough thyroid hormone or because thyroid hormone treatment is otherwise appropriate for my condition. Levothyroxine provides T4 thyroid hormone. Liothyronine provides T3 thyroid hormone. They may be used alone or together depending on my condition and treatment plan.

The goal is to give my body the amount of thyroid hormone it needs without giving me too much. My Physician will check my thyroid blood tests and adjust my dose when needed. Thyroid medicine works best when taken consistently, and certain foods, vitamins, supplements, and other medicines can affect how well it is absorbed.

If my dose is too high, I may have a fast heartbeat, palpitations, anxiety, shaking, sweating, trouble sleeping, weight loss, diarrhea, or feeling unusually hot. These symptoms can mean that I am getting more thyroid hormone than my body needs.

Too much thyroid hormone can put stress on my heart. In some people it can cause an abnormal heart rhythm or other serious heart problems. Long-term over-treatment can also weaken bones and increase the risk of fractures. These risks are especially important in people who already have heart disease or are at increased risk for bone loss.

If my dose is too low, I may have fatigue, weight gain, feeling cold, constipation, dry skin, low mood, or brain fog. These symptoms can mean that my thyroid hormone level is still too low.

I will seek urgent medical care for severe chest pain, fainting, severe shortness of breath, or a very fast or irregular heartbeat.

Other choices depend on my condition and may include monitoring without medication, levothyroxine alone, another thyroid treatment, or evaluation by another thyroid specialist.

By signing this consent, I understand why thyroid hormone has been recommended. I understand the possible benefits, what can happen if the dose is too high or too low, the need for blood-test monitoring, alternatives, and the option of no treatment.

FDA Approval and Compounded Medications

Not all medications discussed or prescribed in this practice are FDA-approved for the specific use described in this consent. Some medications may be used off-label, which means the medication is FDA-approved for another use but is being prescribed for a different medical reason. Some medications may also be compounded, which means they are specially prepared by a pharmacy. Compounded medications are not FDA-approved, and the FDA does not review them for safety, effectiveness, or quality before they are made and dispensed in the same way it reviews FDA-approved medications.

I have the right to ask questions and to choose an FDA-approved treatment, another treatment option, or no treatment when appropriate.

Although some medications may not be FDA-approved, medications prescribed by Arizona Endocrinology are obtained from pharmacies that meet applicable federal and state requirements. When applicable, medications are tested by the pharmacy and/or an independent laboratory for identity, potency, purity, and quality before they are dispensed.